CD133+ Autologous Cells After Myocardial Infarction
TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.
TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).
- To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.
- To evaluate the disease-related morbility of the target population.
|Acute Myocardial Infarction||Procedure: cd133+cell intracoronary administration||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction|
- myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
- Ejection fraction (%) evaluated by 2D echocardiography;
- perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
- Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||October 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400959
|Cell Factory, department of regenerative medicine, Policlinic of Milan|
|Principal Investigator:||Rosaria Giordano, MD||Cell Factory Department of Regenerative Medicine Policlinic Milan|